Luca Bertoglio
@unibs.it
Associated professor - Department of Sperimental and Clinical Sciences (DSCS) of Brescia University
Division of Vascular Surgery
Scopus Publications
Scholar Citations
Scholar h-index
Scholar i10-index
Scopus Publications
Andrea Melloni, Mario D’Oria, Pietro Dioni, Deborah Ongaro, Giovanni Badalamenti, Sandro Lepidi, Stefano Bonardelli, and Luca Bertoglio
MDPI AG
Vascular plugs are an evolving family of vessel occluders providing a single-device embolization system for large, high-flow arteries. Nitinol mesh plugs and polytetrafluoroethylene membrane plugs are available in different configurations and sizes to occlude arteries from 3 to 20 mm in diameter. Possible applications during complex endovascular aortic procedures are aortic branch embolization to prevent endoleak or to gain an adequate landing zone, directional branch occlusion, and false lumen embolization in aortic dissection. Plugs are delivered through catheters or introducers, and their technical and clinical results are comparable to those of coil embolization. Plugs are more accurate than coils as repositionable devices, less prone to migration, and have fewer blooming artifacts on postoperative computed tomography imaging. Their main drawback is the need for larger delivery systems. This narrative review describes up-to-date techniques and technology for plug embolization in complex aortic repair.
Sandro Lepidi, Davide Mastrorilli, Michele Antonello, Andrea Kahlberg, Paolo Frigatti, Gabriele Piffaretti, Stefano Bonardelli, Mauro Gargiulo, Gian Franco Veraldi, Reinhold Perkmann,et al.
Elsevier BV
Luca Bertoglio, Victor Bilman, Fiona Rohlffs, Giuseppe Panuccio, Roberto Chiesa, and Tilo Kölbel
SAGE Publications
Purpose: To describe the implantation steps of the latest generation of candy-plug device (third CP generation [CP III]) and to illustrate its possible pitfalls by discussing a case in whom this device was employed to occlude the false lumen (FL) of a chronic type B aortic dissection. Technique: A 69 year-old male patient who underwent a frozen elephant trunk arch repair due to residual type A aortic dissection developed a FL aneurysmal degeneration limited to the descending thoracic aorta. Two thoracic stent-grafts were deployed into the true lumen up to the celiac trunk origin. Then, the FL was occluded with a self-occluding CP III device (Cook Medical, Bloomington, Indiana), placed at the same level as the distal thoracic stent-graft. The distal un-stented sleeve was pushed upward to allow immediate occlusion of its central lumen, avoiding interference with reno-visceral arteries arising from the FL. Both intraoperative transesophageal echocardiography and follow-up computed tomographic angiography scan demonstrated complete FL thrombosis. Conclusion: The introduction of CP III with its self-occluding mechanism helped to shorten and standardize the procedure. However, adjunctive steps may be needed to immediately obtain FL occlusion and avoid hampering the perfusion of vessels arising from the FL.
Luca Bertoglio, Alice Lopes, Enrico Rinaldi, Matteo Bossi, Raffaella Berchiolli, Mauro Ferrari, and Roberto Chiesa
SAGE Publications
The absence of an adequate ileo-femoral access is usually considered an absolute contraindication to fenestrated and branched aortic repairs. Alternative routes and dedicated stent-graft designs have been advocated. Hereby, we describe the case of a 73-year-old man with a recurrent type IV thoracoabdominal aortic aneurysm and complete thrombotic pararenal aortic occlusion treated successfully with a tri-branch custom-made endograft deployed via a transaxillary access.
Marina Dias-Neto, Andrea Vacirca, Ying Huang, Aidin Baghbani-Oskouei, Tomasz Jakimowicz, Bernardo C. Mendes, Tilo Kolbel, Jonathan Sobocinski, Luca Bertoglio, Barend Mees,et al.
Ovid Technologies (Wolters Kluwer Health)
Objective: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). Background: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. Methods: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006–2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. Results: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P<0.001) and rates of MAEs (34% vs 20%, P<0.001). Median follow-up was 15 months (interquartile range, 7–37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P<0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50–2.44; P<0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63–3.62; P<0.001). Conclusions: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.
Nikolaos Tsilimparis, Ryan Gouveia e Melo, Andres Schanzer, Jonathan Sobocinski, Martin Austermann, Roberto Chiesa, Timothy Resch, Mauro Gargiulo, Carlos Timaran, Blandine Maurel,et al.
Elsevier BV
Alessandro Grandi, Luca Bertoglio, Sandro Lepidi, Tilo Kölbel, Kevin Mani, Jacob Budtz-Lilly, Randall DeMartino, Salvatore Scali, Lydia Hanna, Nicola Troisi,et al.
MDPI AG
Purpose. The present scoping review aims to describe and analyze available clinical data on the most commonly reported risk prediction indices in vascular surgery for perioperative mortality, with a particular focus on ruptured abdominal aortic aneurysm (rAAA). Materials and Methods. A scoping review following the PRISMA Protocols Extension for Scoping Reviews was performed. Available full-text studies published in English in PubMed, Cochrane and EMBASE databases (last queried, 30 March 2023) were systematically reviewed and analyzed. The Population, Intervention, Comparison, Outcome (PICO) framework used to construct the search strings was the following: in patients with aortic pathologies, in particular rAAA (population), undergoing open or endovascular surgery (intervention), what different risk prediction models exist (comparison), and how well do they predict post-operative mortality (outcomes)? Results. The literature search and screening of all relevant abstracts revealed a total of 56 studies in the final qualitative synthesis. The main findings of the scoping review, grouped by the risk score that was investigated in the original studies, were synthetized without performing any formal meta-analysis. A total of nine risk scores for major vascular surgery or elective AAA, and 10 scores focusing on rAAA, were identified. Whilst there were several validation studies suggesting that most risk scores performed adequately in the setting of rAAA, none reached 100% accuracy. The Glasgow aneurysm score, ERAS and Vancouver score risk scores were more frequently included in validation studies and were more often used in secondary studies. Unfortunately, the published literature presents a heterogenicity of results in the validation studies comparing the different risk scores. To date, no risk score has been endorsed by any of the vascular surgery societies. Conclusions. The use of risk scores in any complex surgery can have multiple advantages, especially when dealing with emergent cases, since they can inform perioperative decision making, patient and family discussions, and post hoc case-mix adjustments. Although a variety of different rAAA risk prediction tools have been published to date, none are superior to others based on this review. The heterogeneity of the variables used in the different scores impairs comparative analysis which represents a major limitation to understanding which risk score may be the “best” in contemporary practice. Future developments in artificial intelligence may further assist surgical decision making in predicting post-operative adverse events.
Aaron Thomas Fargion, Davide Esposito, Sara Speziali, Raffaele Pulli, Enrico Gallitto, Gianluca Faggioli, Mauro Gargiulo, Luca Bertoglio, Germano Melissano, Roberto Chiesa,et al.
Elsevier BV
Karl Wilhelm Olsson, Kevin Mani, Anne Burdess, Suzannah Patterson, Salvatore T. Scali, Tilo Kölbel, Giuseppe Panuccio, Ahmed Eleshra, Luca Bertoglio, Vincenzo Ardita,et al.
American Medical Association (AMA)
ImportanceEndovascular treatment is not recommended for aortic pathologies in patients with connective tissue diseases (CTDs) other than in redo operations and as bridging procedures in emergencies. However, recent developments in endovascular technology may challenge this dogma.ObjectiveTo assess the midterm outcomes of endovascular aortic repair in patients with CTD.Design, Setting, and ParticipantsFor this descriptive retrospective study, data on demographics, interventions, and short-term and midterm outcomes were collected from 18 aortic centers in Europe, Asia, North America, and New Zealand. Patients with CTD who had undergone endovascular aortic repair from 2005 to 2020 were included. Data were analyzed from December 2021 to November 2022.ExposureAll principal endovascular aortic repairs, including redo surgery and complex repairs of the aortic arch and visceral aorta.Main Outcomes and MeasuresShort-term and midterm survival, rates of secondary procedures, and conversion to open repair.ResultsIn total, 171 patients were included: 142 with Marfan syndrome, 17 with Loeys-Dietz syndrome, and 12 with vascular Ehlers-Danlos syndrome (vEDS). Median (IQR) age was 49.9 years (37.9-59.0), and 107 patients (62.6%) were male. One hundred fifty-two (88.9%) were treated for aortic dissections and 19 (11.1%) for degenerative aneurysms. One hundred thirty-six patients (79.5%) had undergone open aortic surgery before the index endovascular repair. In 74 patients (43.3%), arch and/or visceral branches were included in the repair. Primary technical success was achieved in 168 patients (98.2%), and 30-day mortality was 2.9% (5 patients). Survival at 1 and 5 years was 96.2% and 80.6% for Marfan syndrome, 93.8% and 85.2% for Loeys-Dietz syndrome, and 75.0% and 43.8% for vEDS, respectively. After a median (IQR) follow-up of 4.7 years (1.9-9.2), 91 patients (53.2%) had undergone secondary procedures, of which 14 (8.2%) were open conversions.Conclusions and RelevanceThis study found that endovascular aortic interventions, including redo procedures and complex repairs of the aortic arch and visceral aorta, in patients with CTD had a high rate of early technical success, low perioperative mortality, and a midterm survival rate comparable with reports of open aortic surgery in patients with CTD. The rate of secondary procedures was high, but few patients required conversion to open repair. Improvements in devices and techniques, as well as ongoing follow-up, may result in endovascular treatment for patients with CTD being included in guideline recommendations.
Luca Bertoglio, Andrea Melloni, Carlotta Bugna, Camilla Grignani, Daria Bucci, Emanuela Foglia, Roberto Chiesa, Anna Odone, Eleonora Bossi, Silvia Colucci,et al.
Elsevier BV
Giulianna B. Marcondes, Nolan C. Cirillo-Penn, Emanuel R. Tenorio, Donald J. Adam, Carlos Timaran, Martin J. Austermann, Luca Bertoglio, Tomasz Jakimowicz, Michele Piazza, Maciej T. Juszczak,et al.
Ovid Technologies (Wolters Kluwer Health)
Objective: To assess outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of Extent I-III thoracoabdominal aortic aneurysms (TAAAs) without prophylactic cerebrospinal fluid drainage (CSFD). Background: Prophylactic CSFD has been routinely used during endovascular TAAA repair, but concerns about major drain-related complications have led to revising this paradigm. Methods: We reviewed a multicenter cohort of 541 patients treated for Extent I-III TAAAs by FB-EVAR without prophylactic CSFD. Spinal cord injury (SCI) was graded as ambulatory (paraparesis) or nonambulatory (paraplegia). Endpoints were any SCI, permanent paraplegia, response to rescue treatment, major drain-related complications, mortality, and patient survival. Results: There were 22 Extent I, 240 Extent II and 279 Extent III TAAAs. Thirty-day mortality was 3%. SCI occurred in 45 patients (8%), paraparesis occurring in 23 (4%) and paraplegia in 22 patients (4%). SCI was more common in patients with Extent I-II compared with Extent III TAAAs (12% vs. 5%, P=0.01). Rescue treatment included permissive hypertension in all patients, with CSFD in 22 (4%). Symptom improvement was noted in 73%. Twelve patients (2%) had permanent paraplegia. Two patients (0.4%) had major drain-related complications. Independent predictors for SCI by multivariate logistic regression were sustained perioperative hypotension [odds ratio (OR): 4.4, 95% confidence interval (95% CI): 1.7–11.1], patent collateral network (OR: 0.3, 95% CI: 0.1–0.6), and total length of aortic coverage (OR: 1.05, 95% CI: 1.01–1.10). Patient survival at 3 years was 72%±3%. Conclusion: FB-EVAR of Extent I-III TAAAs without CSFD has low mortality and low rates of permanent paraplegia (2%). SCI occurred in 8% of patients, and rescue treatment improved symptoms in 73% of them.
Jacob Budtz-Lilly, Mario D’Oria, Enrico Gallitto, Luca Bertoglio, Tilo Kölbel, David Lindström, Nuno Dias, Goran Lundberg, Dittmar Böckler, Gianbattista Parlani,et al.
Ovid Technologies (Wolters Kluwer Health)
Objective: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). Methods: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. Background: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. Results: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4–12) years, 5 (3–8) for pEVAR, and 10 (6–14) for pOAR, P<0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P=0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P=0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P=0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P=0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). Conclusions: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.
Ahmed Eleshra, Stephan Haulon, Luca Bertoglio, Thomas Lindsay, Fiona Rohlffs, Nuno Dias, Nikolaos Tsilimparis, Giuseppe Panuccio, Tilo Kölbel, Justine Mougin,et al.
Elsevier BV
Thomas Schachner, Roman Gottardi, Jürg Schmidli, Thomas R Wyss, Jos C Van Den Berg, Nikolaos Tsilimparis, Joseph Bavaria, Luca Bertoglio, Andreas Martens, Martin Czerny,et al.
Oxford University Press (OUP)
Abstract OBJECTIVES Spinal cord injury is detrimental for patients undergoing open or endovascular thoracoabdominal aortic aneurysm (TAAA) repair. The aim of this survey and of the modified Delphi consensus was to gather information on current practices and standards in neuroprotection in patients undergoing open and endovascular TAAA. METHODS The Aortic Association conducted an international online survey on neuromonitoring in open and endovascular TAAA repair. In a first round an expert panel put together a survey on different aspects of neuromonitoring. Based on the answers from the first round of the survey, 18 Delphi consensus questions were formulated. RESULTS A total of 56 physicians completed the survey. Of these, 45 perform open and endovascular TAAA repair, 3 do open TAAA repair and 8 do endovascular TAAA repair. At least 1 neuromonitoring or protection modality is utilized during open TAAA surgery. Cerebrospinal fluid (CSF) drainage was used in 97.9%, near infrared spectroscopy in 70.8% and motor evoked potentials or somatosensory evoked potentials in 60.4%. Three of 53 centres do not utilize any form of neuromonitoring or protection during endovascular TAAA repair: 92.5% use CSF drainage; 35.8%, cerebral or paravertebral near infrared spectroscopy; and 24.5% motor evoked potentials or somatosensory evoked potentials. The utilization of CSF drainage and neuromonitoring varies depending on the extent of the TAAA repair. CONCLUSIONS The results of this survey and of the Delphi consensus show that there is broad consensus on the importance of protecting the spinal cord to avoid spinal cord injury in patients undergoing open TAAA repair. Those measures are less frequently utilized in patients undergoing endovascular TAAA repair but should be considered, especially in patients who require extensive coverage of the thoracoabdominal aorta.
Alessandro Grandi, Andrea Melloni, Mario D'Oria, Sandro Lepidi, Stefano Bonardelli, Tilo Kölbel, and Luca Bertoglio
Elsevier BV
For a long time, parallel grafting, physician-modified endografts, and, more recently, in situ fenestration were the only go-to endovascular options for ruptured thoracoabdominal aortic aneurysm, offered mixed results, and depended mainly on the operator's and center's experience. As custom-made devices have become an established endovascular treatment option for elective thoracoabdominal aortic aneurysm, they are not a viable option in the emergency setting, as endograft production can take up to 4 months. The development of off-the-shelf (OTS) multibranched devices with a standardized configuration has allowed the treatment of ruptured thoracoabdominal aortic aneurysm with emergent branched endovascular procedures. The Zenith t-Branch device (Cook Medical) was the first readily available graft outside the United States to receive the CE mark (in 2012) and is currently the most studied device for those indications. A new device, the E-nside thoracoabdominal branch endoprosthesis OTS multibranched endograft (Artivion), has been made commercially available, and the GORE EXCLUDER thoracoabdominal branch endoprosthesis OTS multibranched endograft (W. L. Gore and Associates) is expected to be released in 2023. Due to the lack of guidelines on ruptured thoracoabdominal aortic aneurysm, this review summarizes the available treatment options (ie, parallel grafts, physician-modified endografts, in situ fenestrations, and OTS multibranched devices), compares the indications and contraindications, and points out the evidence gaps that should be filled in the next decade.
Luca Bertoglio, Alessandro Grandi, Gian Franco Veraldi, Raffaele Pulli, Michele Antonello, Stefano Bonvini, Giacomo Isernia, Raffaello Bellosta, Francesco Buia, Roberto Silingardi,et al.
Elsevier BV
Marina Dias-Neto, Emanuel R. Tenorio, Ying Huang, Tomasz Jakimowicz, Bernardo C. Mendes, Tilo Kölbel, Jonathan Sobocinski, Luca Bertoglio, Barend Mees, Mauro Gargiulo,et al.
Elsevier BV
Luca Bertoglio, Gustavo Oderich, Andrea Melloni, Mauro Gargiulo, Tilo Kölbel, Donald J. Adam, Luca Di Marzo, Gabriele Piffaretti, Christopher J. Agrusa, Wouter Van den Eynde,et al.
Elsevier BV
Silvia Ajello, Marina Pieri, Luca Bertoglio, Savino Altizio, Pasquale Nardelli, and Anna Mara Scandroglio
Wiley
Blood flow obstruction at the level of the outflow graft is a rare but severe complication of LVAD support. We present a series of five patients supported with HeartMate3 LVAD (Abbott Labs, Chicago, IL) that developed an outflow graft obstruction after 607-1250 days of support, during prolonged antithrombotic therapy. Three patients presented with severe symptoms of heart failure, were treated with endovascular stenting and experienced full recovery. Preoperative computed tomography angiography and intraoperative angiography together with intravascular ultrasound provided diagnosis and guided treatment. In two patients, outflow obstruction was an occasional finding at imaging without heart failure symptoms and a "watchful waiting" approach was adopted: delayed treatment in one of them was futile. This late adverse event is peculiar for its pathophysiology and not yet discussed among the mechanical circulatory support community.
Enrico Rinaldi, Andrea Melloni, Enrico Gallitto, Aaron Fargion, Giacomo Isernia, Andrea Kahlberg, Luca Bertoglio, Gianluca Faggioli, Massimo Lenti, Carlo Pratesi,et al.
SAGE Publications
Purpose: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). Materials and Methods: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. Results: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69–162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53–21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55–12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12–26.18). Conclusion: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.
Emanuel R. Tenorio, Gustavo S. Oderich, Andres Schanzer, Adam W. Beck, Mauro Gargiulo, Mark A. Farber, Bijan Modarai, Tomasz Jakimowicz, Luca Bertoglio, Roberto Chiesa,et al.
Elsevier BV
Andrea Kahlberg, Yamume Tshomba, Domenico Baccellieri, Luca Bertoglio, Enrico Rinaldi, Vincenzo Ardita, Elisa Colombo, Umberto Moscato, Germano Melissano, Roberto Chiesa,et al.
Elsevier BV
Andrea Melloni and Luca Bertoglio
Elsevier BV
Mario D’Oria, Rosalba Lembo, Tal M. Hörer, Todd Rasmussen, Kevin Mani, Gianbattista Parlani, Anna Maria Ierardi, Gian Franco Veraldi, Andrea Melloni, Stefano Bonardelli,et al.
SAGE Publications
Objective: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA). Methods: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts’ responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round’s answers was also graded using Cohen’s kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa. Results: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making. Conclusions: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology. Clinical Impact This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.
Giovanni Torsello, Luca Bertoglio, Richard Kellersmann, Jan J. Wever, Hans van Overhagen, and Konstantinos Stavroulakis
SAGE Publications
Purpose: Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. Materials and Methods: Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. Results: The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. Conclusions. In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. Clinical Impact Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System. ClinicalTrials.gov Identifier: NCT02477111.